Founder Profile

Pew is an independent nonprofit organization – the sole beneficiary of seven individual trusts established between 1948 and 1979 by four generous and committed siblings. Learn more about one of our founders: Mary Ethel Pew.

Project

Drug Safety Project

Pew’s drug safety project works to ensure a trustworthy, reliable pharmaceutical manufacturing and distribution system. Our current focus is on pharmaceutical compounding, the creation of medications for patients whose clinical needs cannot be met by commercially available products approved by the Food and Drug Administration.

For example, if a patient who cannot swallow pills needs a medicine that is FDA-approved only in pill form, a compounding pharmacy can make the drug as a liquid. Pew’s work on drug safety aims to preserve access to compounded medications for people who need them while helping to protect those patients from the risks of drugs produced under dangerous and illegal conditions.

additional resources

Pharmaceutical compounding is the creation of medications for patients whose clinical needs cannot be met by commercially available products approved by the Food and Drug Administration. For example, if a patient who cannot swallow pills needs a liquid version of a medicine that is FDA-approved only in pill form, a compounding pharmacy can make the medication.

More than five years have passed since contaminated injections compounded at a single pharmacy caused 76 deaths and 778 illnesses in a nationwide outbreak of fungal meningitis, a tragedy that made clear that the complex, technical practice of drug compounding was not subject to a level of oversight appropriate to its potential risks to patients. Since then, state and federal officials have been re-examining the laws and regulations governing compounding, and working to strengthen them. Compounding is the creation of medications tailored to patients whose clinical needs cannot be met by U.S. Food and Drug Administration-approved products.&nbsp;

Pew&rsquo;s drug safety project has identified more than 50 reported compounding errors or potential errors associated with 1,197 adverse events, including 99 deaths, from 2001 to 2016. Because many such events may go unreported, this chart is likely an underestimation of the number of compounding errors since 2001. Contamination of sterile products was the most common error; others were the result of pharmacists&rsquo; and technicians&rsquo; miscalculations and mistakes in filling prescriptions.

In 2012 and 2013, patients across the country were injected with fungus-contaminated drugs that had been made and distributed by a Massachusetts compounding pharmacy. More than 60 people died of fungal meningitis, and more than 750 people in 20 states became seriously ill. Many of these patients still struggle with chronic, even disabling, health problems, including pain and mobility challenges caused by the meningitis, and impaired memory and concentration, side effects of a medication used to treat the infection.